Surgical instrument having a fastener delivery mechanism

ABSTRACT

A delivery device for delivering a plurality of individual surgical fasteners is disclosed. The delivery device has a drive mechanism having a distal and a proximal end, and a first and a second opposing member. The members are moveable proximally and distally with respect to the delivery device, and individually with respect to each other. The device further includes at least one surgical fastener located between the first and the second members. Each of the at least one surgical fasteners has a proximal end and a distal end. The surgical fasteners are preferably made from a superelastic nickel titanium alloy. Additionally an actuator having at least three sequential positions is included. The first position of the actuator is for moving the drive mechanism distally. The second position is for moving the first member proximally to partially deploy the distal end of the fastener. The third position of the actuator is for moving the second member proximally, to fully deploy the distal end of the fastener.

This application is related to the following copending patentapplications: application Ser. No. 09/692,633 U.S. Pat. No. 6,447,524,application Ser. No. 09/692,627 and application Ser. No. 09/692,636,U.S. Pat. No. 6,425,900 which are hereby incorporated herein byreference.

FIELD OF THE INVENTION

The present invention relates, in general, to a surgical instrument and,more particularly, to a surgical instrument having a feeding mechanismfor feeding at least one surgical fastener from a surgical instrument toattach a prosthetic in the repair of a defect in tissue such as aninguinal hernia.

BACKGROUND OF THE INVENTION

An inguinal hernia is a condition where a small loop of bowel orintestine protrudes through a weak place or defect within the lowerabdominal muscle wall or groin of a patient. This condition commonlyoccurs in humans, particularly males. Hernias of this type can be acongenital defect wherein the patient is born with this problem, or canbe caused by straining or lifting heavy objects. Heavy lifting is knownto create a large amount of stress upon the abdominal wall and can causea rupture or tearing at a weak point of the abdominal muscle to createthe defect or opening. In any case, the patient can be left with anunsightly bulge of intestinal tissue protruding through the defect,pain, reduced lifting abilities, and in some cases, impaction of thebowel, or possibly other complications if the flow of blood is cut offto the protruding tissue.

A common solution to this problem is surgery. In the surgical procedure,the defect is accessed and carefully examined, either through an openincision or endoscopically through an access port such as a trocar. Ineither case, the careful examination can be well appreciated, as anetwork of vessels and nerves exist in the area of a typical defect,which requires a surgeon to conduct a hernia repair with great skill andcaution. Within this area are found vascular structures such as gastricvessels, the external iliac vessels, and the inferior epigastricvessels, and reproductive vessels such as the vas deferens extendingthrough the inguinal floor.

Once the surgeon is familiar with the anatomy of a patient, the surgeoncarefully pushes the bowel back into the patient's abdomen through thedefect. Repairing the defect can involve closure of the defect withsutures or fasteners but generally involves placing a surgicalprosthetic such as a mesh patch over the open defect, and attaching themesh patch to the inguinal floor with conventional suture or withsurgical fasteners. The mesh patch acts as a barrier and preventsexpulsion of bowel through the defect. Suturing of the mesh patch to theinguinal floor is well suited to open procedures but much more difficultand time consuming with endoscopic procedures. With the adoption ofendoscopic surgery, endoscopic surgical instruments that apply surgicalfasteners are falling more and more into use. However, the tissue of theinguinal floor offers special challenges to the surgeon when a needle orfastener is used to penetrate structures such as Cooper's ligament.

At present, there are a variety of surgical instruments and fastenersavailable for the surgeon to use in an endoscopic or open procedure toattach the mesh patch to the inguinal floor. One of the earliest typesof endoscopic surgical instruments used is a surgical stapler. Aplurality or stack of these unformed staples are generally containedwithin a stapling cartridge in a serial fashion, and are sequentiallyadvanced or fed within the instrument by a spring mechanism. A secondaryvalving or feeding mechanism is employed to separate the distal moststaple from the stack, to hold the remainder of the spring loaded stack,and to feed the distal most stapler into the staple forming mechanism.Feeding mechanisms of this type are found in U.S. Pat. No. 5,470,010 byRobert Rothfuss et al. and in U.S. Pat. No. 5,582,616, also by RobertRothfuss et al.

Another hernia mesh attachment instrument uses a helical wire fastenerthat resembles a small section of spring. Multiple helical wirefasteners are stored serially within the 5 mm shaft, and are corkscrewedor rotated into tissue. A load spring is used to bias or feed theplurality of helical fasteners distally within the shaft. A protrusionextends into the shaft to prevent the ejection of the stack of fastenersby the load spring and permits passage of a rotating fastener.Instruments and fasteners of these types are found in U.S. Pat. No.5,582,616 by Lee Bolduc et al., U.S. Pat. No. 5,810,882 by Lee Bolduc etal., and in U.S. Pat. No. 5,830,221 by Jeffrey Stein et al.

Whereas the above surgical instruments are used for hernia fasteningapplications, they use a spring mechanism to feed a plurality offasteners through the surgical instrument. Spring mechanisms typicallyuse a long soft coil spring to push a stack of fasteners through a guideor track within the shaft of the surgical instrument. These types offeeding mechanisms are generally simple and reliable, but require anadditional secondary valving mechanism or protrusion to separate andfeed one fastener from the stack, while preventing the remainder of thestack of fasteners from shooting out of the instrument.

Other surgical fasteners are used for hernia mesh attachment but utilizeeither a reloadable single shot instrument or a rotary magazine thatholds a small number of fasteners. These types of surgical fasteninginstruments can be found in U.S. Pat. No. 5,203,864 and U.S. Pat. No.5,290,297, both by Edward Phillips. These instruments have not gainedacceptance by the surgical community, possibly due to their single shotcapabilities and the large size of the rotary magazine, which canrestrict such an instrument to an open procedure.

Whereas all the above surgical instruments are used for hernia fasteningapplications, they either use a spring mechanism to feed the pluralityof fasteners through the surgical instrument, or a rotary magazine inlieu of a feeding mechanism. Other types of surgical fasteners areavailable, such as surgical clips, and they can utilize feedingmechanisms that do not require the use of a spring to feed the clipsdistally. A reciprocating feeding mechanism is described in U.S. Pat.Nos. 5,601,573, 5,833,700, and 5,921,997 by Fogelberg et al. Fogelberget al. teaches a clip applier with a feeding mechanism that utilizes areciprocating feed bar to feed a serial stack of clips. A feeder shoeoperably engages with and moves with the distally moving feed bar andslidingly engages with the proximally moving feed bar. Thus, the feedershoe indexes or pushes the stack of clips distally with the distallymoving feed bar and remains stationary relative to the proximally movingfeed bar. A valving mechanism is also required to separate the distalmost clip from the stack and to hold the stack stationary as the distalmost clip is applied onto a vessel. Whereas Fogelberg et al. teaches areciprocating feeding mechanism with a single reciprocating member, hedoes not teach the use of the clip applier in the attachment of herniamesh, nor does he teach the individual driving or feeding of each clipby a moving member.

Another fastener feeding mechanism that uses a reciprocation is thatdisclosed in U.S. Pat. No. 4,325,376 by Klieman et al. A clip applierthat stores a plurality of clips in a serial fashion within a clipmagazine is disclosed. The clips are in a stack wherein the proximalmost clip is pushed or fed distally by a pawl that is ratcheted orindexed distally by a reciprocating member or ratchet blade with eachactuation of the instrument. As the pawl indexes distally, it pushes thestack of clips distally. A secondary valving mechanism is alsodescribed. Thus, the feeding mechanism of Klieman et al. teaches the usea single reciprocating member and pawl to push or feed the stack ofclips distally, and requires a secondary valving mechanism to feed thedistal most clip. Additionally, Klieman et al. and does not teach theuse of the clips for the attachment of hernia mesh on tissue.

U.S. Pat. No. 3,740,994 by DeCarlo Jr. describes a novel reciprocatingfeeding mechanism that indexes a plurality of staples or clips, andreadies them for discharge by reciprocating one of a pair of opposingleaf spring assemblies. The staples reside serially within a guide railwith a fixed leaf spring assembly extending into the plane of the guiderail. A reciprocating leaf spring assembly opposedly extends inwardlytowards the fixed leaf spring assembly. As the a reciprocating leafspring assembly moves distally, each of individual leaf springs of theassembly engage a staple and move it distally. The distally movingplurality of staples deflect the local individual leaf springs of thefixed leaf spring assembly, and the deflected leaf springs return to theun-deflected position after passage of the staple. As the moving leafspring assembly moves proximally, the leaf springs of the fixed leafspring assembly hold the staples stationary and prevent distal movementthereof. A secondary guide rail and valving mechanism is provided toseparate a single staple from the stack for forming and to hold thestack of staples stationary as the single clip is formed.

Additionally, similar feeding mechanisms are disclosed in U.S. Pat. No.4,478,220 by Di Giovanni et al. and U.S. Pat. No. 4,471,780 by Menges etal. Both of these related patents teach a reciprocating feedingmechanism that uses one fixed member and one reciprocating member tofeed or index a plurality of clips distally. Angled flexible fingers arehingedly attached to the reciprocating member and operatively engage theclips when moving distally, and slidingly engage with the clips whenmoving proximally. The angled flexible fingers within the fixed memberdeflect out of the way when the clips move distally and spring up tostop proximal movement of the clip after the clip has passed. Asecondary valving mechanism is also disclosed.

Thus, the feeding mechanism of DeCarlo et al., Di Giovanni et al., andMenges et al. operatively engage and individually move each clipdistally between a single reciprocating member and a fixed member.However each instrument requires a secondary valving mechanism for thefeeding and forming of the distal most clip. Additionally, the surgicalinstruments are not indicated for use in the attachment of a prostheticover a hernia.

Unfortunately, the majority of the feeding mechanisms described aboverequire two feeding mechanisms; a primary feeding mechanism to feed aplurality of clips distally, and a secondary valving or feedingmechanism to separate and feed the distal most fastener while preventingthe distal movement of the remaining fasteners. Such additionalmechanisms are costly and increase the size or diameter of theinstrument size. Likewise, the single shot or rotary magazines werefound to have limitations. What is needed is an improved reciprocatingfeeding mechanism that does not require the use of a secondary valvingmechanism, and can simultaneously engage with and independently driveeach fastener distally. Such a mechanism would have two reciprocatingmembers and would provide superior advantages such as lower cost,reduced complexity, and a smaller diameter shaft.

SUMMARY OF THE INVENTION

A delivery device for delivering a plurality of individual surgicalfasteners is disclosed. The delivery device has a drive mechanism havinga distal and a proximal end, and a first and a second opposing member.The members are moveable proximally and distally with respect to thedelivery device, and individually with respect to each other. The devicefurther includes at least one surgical fastener located between thefirst and the second members. Each of the at least one surgicalfasteners has a proximal end and a distal end. The surgical fastenersare preferably made from a superelastic nickel titanium alloy.Additionally an actuator having at least three sequential positions isincluded. The first position of the actuator is for moving the drivemechanism distally. The second position is for moving the first memberproximally to partially deploy the distal end of the fastener. The thirdposition of the actuator is for moving the second member proximally, tofully deploy the distal end of the fastener.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. The invention itself, however, both as toorganization and methods of operation, together with further objects andadvantages thereof, may best be understood by reference to the followingdescription, taken in conjunction with the accompanying drawings inwhich:

FIG. 1 is an isometric view of a surgical instrument wherein a lefthandle half is removed to show the elements within and a trigger is inan open position;

FIG. 2 is an isometric view of the surgical instrument of FIG. 1 whereinthe trigger is moved from the open position of FIG. 1 to a closedposition as shown, and an end effector is extended from the surgicalinstrument;

FIG. 2B is an exploded isometric view of some of the internal elementsof the surgical instrument of FIG. 1, with some elements removed forclarity;

FIG. 3 is a side view, in cross section, of a first side of the surgicalinstrument of FIG. 1 with the left handle half removed, wherein all ofthe internal elements are shown assembled and the trigger is in an openposition;

FIG. 4 is a side view of a second side of the surgical instrument ofFIG. 3 with the left handle half in place and with the right handle halfremoved, showing all of the internal elements therein and the trigger inan open position;

FIG. 5 is a side view of the first side of the surgical instrument ofFIG. 3 wherein the trigger is moved to a partially closed position toextend the end effector from the surgical instrument;

FIG. 6 is a side view of the second side of the surgical instrument ofFIG. 5, wherein the trigger is moved to a partially closed position toextend the end effector from the surgical instrument;

FIG. 7 is a side view of the first side of the surgical instrument ofFIG. 5 wherein the trigger is moved to a fully closed position toretract a first portion of the end effector into the surgicalinstrument, and to expose a portion of a fastener at the end effector;

FIG. 8 is the view of the second side of the surgical instrument of FIG.7, wherein the trigger is moved to a fully closed position to retract anupper portion of the end effector into the surgical instrument, and toexpose a portion of a fastener at the end effector;

FIG. 9 is an isometric view of a fastener of the preferred inventionwherein the fastener of the preferred invention has a pair of distalbarbs and a pair of longer proximal arms, the fastener of the preferredinvention is shown in an unconstrained state;

FIG. 10 is a side-view of FIG. 9 wherein the fastener of the preferredinvention is shown in an unconstrained state;

FIG. 11 is an isometric view of the fastener of FIG. 9 wherein thefastener of the preferred invention is shown in a constrained state asfound within the surgical instrument of FIG. 1;

FIG. 12 is a side-view of FIG. 11 wherein the fastener of the preferredinvention is shown in a constrained state;

FIG. 13 is a bottom-view of FIG. 12 wherein the fastener of thepreferred invention is shown in a constrained state;

FIG. 14 is a cross-sectional side view of a distal end of a shaft of thesurgical instrument of the present invention showing the end effectornormally retracted therein and a plurality of surgical fasteners of thepreferred invention contained therein;

FIG. 15 is a cross-sectional view 10—10 of the shaft and the endeffector of FIG. 9 and showing a passageway and a fastener of thepreferred invention contained therein;

FIG. 16 is a fragmentary perspective view of a surgical grasperinstrument placing a mesh patch over a defect or hernia in the inguinalfloor of the lower abdomen, particularly the left inguinal anatomy;

FIG. 17 is a cross-sectional side view of the inguinal floor of thelower abdomen of FIG. 16 illustrating the placement of the mesh patchabove the tissue in preparation for repair of the defect, according tothe present invention;

FIG. 18 is a cross-sectional side view of the inguinal floor of thelower abdomen wherein the distal end of the shaft of FIG. 14 is pushingthe mesh patch downward onto the inguinal floor, and the end effector ismoving downwardly within the shaft with a fastener contained therein;

FIG. 19 is a cross-sectional side view of the inguinal floor andinstrument of FIG. 18 wherein the end effector of the present inventionis extended from the shaft and into the inguinal floor, the end effectorcontaining a fastener of the preferred invention therein;

FIG. 20 is a cross-sectional side view of the inguinal floor andinstrument of FIG. 19 wherein a first portion of the end effector ispartially retracted into the shaft to deploy a first barb of thefastener of the preferred invention contained therein and to engage thefirst barb with the inguinal floor;

FIG. 21 is the cross-sectional side view of FIG. 20 wherein the firstportion of the end effector of the present invention is fully retractedinto the shaft, the full retraction releasing the arms of the fastenerof the preferred invention into the portion of the shaft previouslyoccupied by the first portion of the end effector;

FIG. 22 is the cross-sectional side view of FIG. 21 wherein a secondportion of the end effector of the present invention is fully retractedinto the shaft, the full retraction engaging a second barb of thefastener of the preferred invention with the inguinal floor and botharms with the shaft;

FIG. 23 is a cross sectional side view of FIG. 22 wherein the shaft ofthe surgical instrument of FIG. 22 has moved upwardly to release thearms of the fastener of the preferred invention, the released armsattaching the surgical mesh to the inguinal floor;

FIG. 24 is a is a fragmentary side-view of a trigger lockout mechanismof the present invention of FIG. 1 with a lockout arm fixably attachedto the pivotable trigger, and operably coupled with a lockout wheel;

FIG. 25 is a fragmentary cross-section view of the lockout mechanism ofthe present invention showing the lockout wheel in an initial positionand engaged with a wheel detent, wherein the lockout arm is movingupwardly from a start position (dashed lines) to a second position(cross section) adjacent to the lockout wheel;

FIG. 26 is a fragmentary cross-section view of FIG. 25 showing theupwardly moving lockout arm engaging with a first tooth of the lockoutwheel, wherein the engagement has rotated the locking wheel one toothcounterclockwise and the locking arm is preparing to return to theinitial position (dashed lines);

FIG. 27 is a fragmentary cross-section view of FIG. 26 showing theupwardly moving lockout arm engaging with a final tooth of the lockoutwheel, wherein the repeated firing of the trigger has rotated thelockout wheel to the final booth, and a locking tab is positioned justbelow the upwardly moving locking arm (cross section);

FIG. 28 is a fragmentary cross-section view of FIG. 27 showing theupwardly moving lockout arm further engaging with a final tooth of thelockout wheel, wherein the lockout wheel has rotated counterclockwise toposition the locking tab below the lockout arm;

FIG. 29 is a fragmentary cross-section view of FIG. 28 showing thedetent arm preventing further rotation of the locking wheel and thelockout arm attached to the trigger captured between a tooth and thelocking arm of the locking wheel.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates, in general, to a surgical instrument and,more particularly, to a surgical instrument having a feeding mechanismfor serially feeding at least one surgical fastener from a surgicalinstrument to attach a prosthetic in place in the repair of a defect intissue such as an inguinal hernia.

By way of example, the present invention is illustrated and described inconjunction with a repair of an inguinal hernia. However, it should beunderstood that the present invention is applicable to various othersurgical procedures that require the repair of defects in tissue.

The Surgical Instrument

As best shown in FIGS. 1 and 2, the surgical instrument or fastenerdelivery device of the present invention is a hand held surgicalinstrument 35 containing a plurality of surgical fasteners or surgicalelements that are generally used for the attachment of a prosthetic totissue, or as a tissue marker. The surgical fasteners 105 of the presentinvention are formed from a superelastic nickel titanium alloy, arestored within the surgical instrument in a compressed or collapsedstate, and expand to an unconstrained state upon release from thesurgical instrument. Actuation of the instrument simultaneously releasesa fastener 105 of the present invention from a distal end of theinstrument and indexes the plurality of fasteners 105 within theinstrument.

Surgical instrument 35 of the present invention has a handle 40, anelongated shaft 92 extending distally from the handle 40, and a trigger85 extending downwardly from the handle 40. Handle 40 has a right half41 and a left half 42 that are generally mirror images of each otherand, in FIGS. 1 and 2, the left half 42 is omitted. Elongated shaft 92is fixedly attached to the handle 40, and is formed from a rigid hollowmaterial such as stainless steel tubing. A grip 43 is fixedly attachedto and extends downwardly from a proximal end of handle 40 and adjacentto the trigger 85. Trigger 85 pivotably mounts within handle 40 and ismoveable from an open position as shown in FIG. 1 to a closed positionadjacent to the grip 43 as shown in FIG. 2. Movement of the trigger 85to the closed position extends an end effector 95 from a distal end ofthe shaft 92 (FIG. 2) for the placement and release of a fastener.

FIG. 2B is an isometric exploded view of the majority of the elementsfound within the surgical instrument 35. The exploded view is providedto familiarize the reader with the key elements contained therein, andthe method of assembly used to form the surgical instrument 35. Forclarity, a number of elements such as the left handle half 42 areremoved. Some of the elements of FIG. 2B are complex in shape and thereader is advised to return to this figure for identification orcomprehension of features referenced below. The elements of the surgicalinstrument 35 are contained within the right and left handle halves41,42 which can be formed from an engineering thermoplastic such asstyrene, polycarbonate, or any one of a number of suitable materials. Ashaft slot 44 is located at the distal end of the upper portion of thehandle halves 41,42 for the reception and retention of the shaft 92therein.

A latch slot 45 is located proximally to and below the shaft slot 44within the right handle half 41. Latch slot 45 is right-angled in shapeand is provided for the reception of a latch 55 therein. Latch 55 has arigid latch post 57 at a distal end and a right-angled beam 56 extendingdistally therefrom. Beam 56 is formed from a resilient spring materialsuch as stainless steel. A distal end of beam 56 is captured and heldwithin the latch slot 45 with a significant amount of the beam 56cantilevering therefrom. The cantilever portion of the beam 56 enablesthe latch post 57 to move freely up and down as the beam 56 deflects.The significance of the latch 55 will be described later.

A first and a second slider 60, 70 are opposing members that extendgenerally proximally and distally throughout the shaft 92 and handle 40of the surgical instrument 35 and form a drive mechanism for thefasteners 105. First and second sliders 60, 70 are moveable proximallyand distally with respect to the surgical instrument 35 and individuallywith respect to each other, and are slidably retained within a pair ofguide slots 46 located within each of the handle halves 41, 42. In FIG.2B, the first and second sliders 60, 70 have a proximal and a distal endand are shown spaced apart prior to assembly to show a plurality offasteners 105 that are stored therebetween. Fasteners 105 extend alongthe entire length of the first and second sliders 60, 70. First andsecond sliders 60, 70 have distal first and second feed members 61, 71that slidably mount within the shaft 92, and a larger proximal first andsecond sequencing member 62, 72 that slidably mount within the handlehalves 41, 42. First and second feed members 61, 71 are semi-circular incross section and have a first and second outer surface 64, 74. A pairof first and second stab posts 64 a, 74 a extends outwardly from adistal end of each first and second outer surface 64, 74 respectively. Afirst and second contact surface 63, 73 completes the semi-circularcross section of the first and second feed members 61, 71 respectively.First and second contact surfaces 63, 73 opposably face each other alongthe entire length of the first and second sliders 60, 70 and have afirst and second fastener channel 65, 75 extending therein. Whenassembled, first and second sliders 60, 70 make sliding contact alongthe entire length of first and second contact surfaces 63, 73 and firstand second fastener channels 65, 75 form a hollow rectangular channelfor the holding and feeding of fasteners 105 serially therethrough (FIG.15).

The fastener channels 65, 75 of the first and second sliders 60, 70 are“U” shaped for the reception of the fasteners 105 therein and have apair of opposed inner surfaces or channel floors for engaging with thefasteners 105. The inner surfaces have a plurality of projections orfastener drive features spaced thereon for engagement with the fasteners105. As best shown in the enlarged FIG. 14, these projections orsawteeth 120, extend proximally to distally along the entire length ofthe floors of the first and second fastener channels 65, 75 and areequally spaced a longitudinal distance “D” apart. The distance “D” isbetween 8 inches and 0.005 inches. The spacing “D” of the presentinvention is 0.475 inches. The spacing “D” can space the fasteners apartfrom one another so that the fasteners do not engage or touch as theyare fed within the surgical instrument 35. Each sawtooth 120 has aproximal incline 122 and a distal step 121 as shown. The role of thesawteeth 120 in the feeding of the fasteners 105 will be discussed indetail later.

At the distal end of the first and second fastener channels 65, 75 are afirst and a second fastener guide 66, 76 respectively which are atapered lead-in at the proximal end of fastener channels 65, 75 toassist in the loading of the fasteners 105 therein. These fastenerguides 66, 76 are generally mirror images of each other. In FIG. 2B, thefirst fastener guide 66 is hidden.

The larger proximal portions of the first and second sliders 60, 70 arethe first and second sequencing members 62, 72, which control the timingand sequencing of a fastener feeding mechanism that releases a fastenerfrom the distal end of the instrument, and indexes or feeds theplurality of fasteners distally within the instrument. The firstsequencing member 62 has a pair of guide ribs 68 extending laterallyoutwardly from either side and a first spring stop 67 extending upwardlyat a proximal end. Guide ribs 68 mount within the guide slots 46 of theright and left handle halves 41, 42 and slidably secure the assembledsliders 60, 70 within the handle 40. A pair of “C” shaped guide channels69 are located underneath and extend longitudinally along the proximalhalf of the first sequencing member 62. The second sequencing member 72has second spring stop 77 located at a proximal end of second sequencingmember 72 and a forked stop 78 extending upwardly at a distal end. A camplate 79 extends outwardly from the far side of the second sequencingmember 72 towards the right handle half 41. A pair of slider ribs 83extends laterally outward along the proximal half of the secondsequencing member 72. First and second sliders 60, 70 can be formed as asingle piece from an engineering thermoplastic such as a liquid crystalpolymer, a polycarbonate, nylon, a styrene or the like.

The first and second sliders 60,70 are slidably interlocked together byinserting the pair of slider ribs 83 located on the second sequencingmember 72 into the pair of guide channels 69 of the first sequencingmember 62. First and second sliders 60,70 are made sharp by theattachment of penetrating members or first and second stab plates 96, 97thereon. First and second stab plates 96, 97 are then attached to thefirst and second sliders 60, 70 by placing first and second stab plates96, 97 over first and second stab posts 64 a, 74 a and then placing theassembled stab plates 96, 97 and first and second sliders 60, 70 intothe hollow shaft 92 to form a shaft sub-assembly. This method of stabplate retention is best shown in FIG. 14. Stab plates 96, 97 are used topierce tissue during the placement of a fastener 105 into tissue and canbe made from a rigid material such as stainless steel.

Next, the shaft sub-assembly is placed into an fastener feeding station(not shown) and the fastener 105 are fed one at a time into the firstand second fastener guides 66, 76 and into the hollow channel formedfrom fastener channels 65, 75. The fastener 105 is inserted until thefastener 105 engages with the feeding mechanism, which will be describedlater. Once the fastener 105 is in place, the first and second sliders60, 70 are reciprocated proximally and distally relative to one anotherto feed or index the fastener 105 further into the shaft sub-assembly.This process is repeated for each new fastener 105 until the first andsecond sliders 60, 70 are fully loaded with a plurality of fasteners 105in a serial fashion. The plurality of fasteners 105 are equally spacedalong the entire length of the first and second sliders 50, 60. Theshaft sub-assembly containing the fastener 105 is then placed into theright handle half 41. Shaft 92 is received in shaft slot 44 and theguide ribs 68 of the first slider 60 are slidably placed into the guideslot 46. Next, a lockout wheel 100 is placed into a wheel receptacle 48located within the right handle half 41 at a position proximal to thepivot bore 47.

A trigger assembly is constructed by placing a trigger plate 87 and alockout arm 88 over a pivot 86 that extends laterally on either side oftrigger 85 and fixably attaching them to trigger 85 with a pair of pins89. A drive arm 90 extends upwardly from the trigger plate 87 and aspring post 91 extends from the far side of the trigger plate 87 towardsthe right handle half 41. An end of a trigger spring 104 (FIG. 3) isthen placed over spring post 91. The trigger assembly is then placedinto the right handle half 41 by placing the far side pivot 86 (notshown) into a pivot bore 47. Trigger 85, trigger plate 87, and lockoutarm 88 are shown as separate pieces but can alternately be constructedas a single piece from an engineering thermoplastic such aspolycarbonate, styrene or the like.

FIG. 3 shows the fully assembled elements of the handle 40. Prior to theview shown in FIG. 3, the free end of the trigger spring 104 has beenstretched and attached to a spring pin 49 of the grip 43. The attachmentof the free end of the trigger spring 104 tensions trigger spring 104,and biases the trigger 85 to the open position shown. Next, a firstreturn spring 115 was compressed and placed into a first spring pocketformed between the first spring stop 67 of the first slider 60 and afirst spring rib 50 of the handle halves 41, 42. A second return spring116 was also compressed and placed into a second spring pocket formedbetween the second spring stop 77 of the second slider 70 and a secondspring rib 51. Finally, the left handle half 42 was attached to theright handle half 41 to complete the assembly of the surgical instrument35. The left handle half 42 has been removed for clarity.

Actuator Mechanism

The instrument of FIGS. 3-8 shows the operation of the actuator orsequencing mechanism that controls the timing and movement of elementswithin the surgical instrument 35. The actuator mechanism engaged by theactuation of the trigger 85 and moves the drive mechanism or first andsecond sliders 60,70 into at least three sequential positions. Actuationof the trigger 85 simultaneously moves the first and second sliders 60,70 distally from a first proximal position to a second distal position,then returns the first slider 60 to the proximal position, and finallyreturns the second slider 70 to the proximal position. This sequence ofmotion advances the plurality of fasteners 105 distally, and deploys thedistal end of the fastener into tissue in two steps. The actuatormechanism consists of the latch 55; the trigger assembly describedabove, the first and second return springs 115, 116, the first andsecond sliders 60, 70.

FIG. 3 shows a first or left side view of the surgical instrument ofFIG. 1 with the right handle half 41 in place, the left handle half 42removed for clarity, and the trigger 85 in the initial open position.The first and second sliders and second return springs 115, 116 arebiasing the first and second sliders 60, 70 distally within the handles41, 42. The trigger 85 of the trigger assembly is in the full openposition with the drive arm 90 poised to operatively engage a proximalend of the guide rib 68 of the first sequencing member 62. First andsecond sliders 60, 70 are in the first proximal position.

FIG. 4 shows the second or right side view of the surgical instrument ofFIG. 3 with the left handle half 42 in place and with the right handlehalf 41 removed. The latch 55 is visible in this view, and the latchpost 57 of latch 55 is operatively engaged with a first ramp 69 alocated on the distal end of the first sequencing member 62. A portionof the first and second spring ribs 50, 51 and the latch slot 45 of theright handle half 41 are shown in cross-section for clarity.

FIGS. 5 and 6 show the left and right side views of the assembledsurgical instrument 35 respectively, and show the first and secondsliders 60, 70 translated or moved distally from the first position ofFIGS. 3-4 to the second position by the trigger 85. The distal movementof first and second sliders 60, 70 has extended the end effector 95 fromthe distal end of the shaft 92. The trigger 85 is in a first partiallyclosed position and is poised to release the first slider 60 from thedrive arm 90 of the trigger assembly.

In FIG. 5, as trigger 85 rotates counter-clockwise towards the grip 43,the drive arm 90 rotates into operative engagement with the guide rib 68and moves the first slider 60 distally. As first slider 60 movesdistally, the forked stops 78 of the second slider 70 are contacted,pushing the second slider 70 distally. The distally moving first andsecond sliders 60, 70 compress the first and second return springs 115,116 as shown. The lockout arm 88 of the trigger assembly is movingupwardly, and is rotating the lockout wheel 100.

In FIG. 6, as the first and second sliders 60, 70 move distally, theydeflect the latch post 57 of the latch 55 downwardly to slide along thefirst ramp 69 a of the first slider 60 and a second ramp 80 of thesecond slider 70. Latch post 57 of the latch 55 passes the second ramp80 and deflects upwardly to lock against a third ramp 81 of the secondslider 70 and against a bottom surface 62 a of the first sequencingmember 62. With the latch 55 in this position, the second slider 70 islocked in the distal position and cannot move proximally.

FIGS. 7 and 8 show the left and right side views of the assembledsurgical instrument 35 respectively, after the first slider 60 hasreciprocated or returned back to the first proximal position of FIGS. 3and 4 to partially release a fastener 105 from the end effector 95.

As shown in FIG. 7, after the guide rib 68 is released from the drivearm 90, the first slider 60 reciprocates distally to the first proximalposition from the second distal position shown in FIGS. 5 and 6. Slider60 was returned to the proximal position by first return spring 115. Theproximal movement of the first slider 60 retracted the first stab plate96 proximally into the shaft 92 and released a distal end of thefastener 105 as shown. The lockout arm 88 moved upwardly from anddisengaged with the lockout wheel 100.

In FIG. 8, as first sequencing member 62 moves proximally, the bottomsurface 62 a of the first sequencing member 62 moves distally away fromthe latch post 57 enabling the latch 55 to deflect upwardly to theun-deflected position shown in FIG. 3. This movement unlocks the secondsequencing member 72. With the second sequencing member 72 unlocked, thecompressed second return spring 116 will reciprocate the second slider70 back to the original proximal position of FIG. 3. As the secondslider 70 reciprocates back to the first proximal position, latch post57 is deflected upwardly by the third ramp 81 of the cam plate 79 totravels over a top surface 82 of the distally moving cam plate 79 andreturns to the position of FIG. 3. At this point, if an instrumentlockout is not actuated, the trigger 85 is released to bring theelements of the instrument back to the positions shown in FIG. 3.

The Fastener

FIGS. 9-13 are expanded views showing the novel surgical element,anchor, or fastener 105 of the present invention. A plurality offasteners 105 of the present invention are contained serially within thesurgical instrument 35 (FIG. 2B) and are used to fasten or suture aprosthetic such as a surgical mesh pad onto tissue. The fastener 105 ofthe present invention is elastic and is shown in its originalunconstrained state in FIGS. 9 and 10. When fastener 105 is distorted orconstrained, it will return to its original shape when released.Fastener 105 can be formed or stamped from a sheet or foil of apseudoelastic or superelastic nickel titanium alloy to take advantage ofpseudoelastic or superelastic properties thereof, or an elastic orspring grade of steel, stainless steel, copper, or other titaniumalloys.

Most preferably, fastener 105 is made from an alloy comprising fromabout 50.5% (as used herein these percentages refer to atomicpercentages) Ni to about 60% Ni, and most preferably about 55% Ni, withthe remainder of the alloy Ti. Preferably, the fastener is such that itis superelastic at body temperature, and preferably has an Af in therange from about 24° C. to about 37° C. The superelastic design of thefastener 105 makes it crush recoverable which makes it possible to storea large fastener 105 within a small diameter shaft 92.

As mentioned above, it is preferred that the fastener 105 of the presentinvention be made from a superelastic alloy and most preferably made ofan alloy material having greater than 50.5 atomic % Nickel and thebalance titanium. Greater than 50.5 atomic % Nickel allows for an alloyin which the temperature at which the martensite phase transformscompletely to the austenite phase (the Af temperature) is below humanbody temperature and preferably is about 24° C. to about 37° C. so thataustenite is the only stable phase at body temperature.

The unconstrained fastener 105 of FIGS. 9 and 10 has a generally planarcontinuous body member 109 having a first (distal) end and a second(proximal) end. At least one barb extends from the distal end, and atleast two barbs extend from the proximal end. The continuous body member109 has a distal tip 106 which is rounded or blunt, as the fastener 105does not need to penetrate tissue. Alternately, the distal tip 106 ofthe fastener 105 can be made sharp or pointed if desired. A first and asecond barb 107,108 extend proximally and axially away from the distaltip 106 and away from the body member 109. The first and second barbs107, 108 can be curved. The distal end of the body member 109 has a pairof barbs or a first and a second leg 110,111 that extend distally fromthe body member 109 and away from each other in different directions.First and second legs 110,111 of the present invention engage the innersurfaces of the first and second members 60,70, can also be curvedoutwardly from the body member 109, and can form the evertedconfiguration f FIGS. 9 and 10. The ends of the first and second barb107,108, and first and second leg 110,111, can be blunt.

FIGS. 11-13 shows an isometric view, a side view, and a bottom view ofthe fastener 105 of the present invention wherein the fastener 105 isshown in a constrained state that the fastener 105 assumes when storedwithin the surgical instrument 35 (FIG. 1). The fastener 105 will revertto the unconstrained shape of FIGS. 9 and 10 when released from thesurgical instrument 35. Surgical fastener 105 can also be used as amarker when placed in tissue. That is, the material of the fastener 105is such that it appears in diagnostic tests such as MRI scans, CATscans, X-rays, or ultrasound, and the surgeon can readily identify thelocation of the fastener relative to other body features.

The Drive Mechanism

FIGS. 14 and 15 are enlarged partial cross-sectional views of the distalend of the shaft 92 of FIG. 3 showing the first and second sliders 60,70or walking beams at the first or un-actuated position wherein they arerecessed into the shaft 92, and the fasteners 105 containedtherebetween. At the first distal position, the trigger 85 of thesurgical instrument 35 is fully open (FIG. 3) and the sawteeth 120 ofthe first slider 60 are lined up with and directly opposed from thesawteeth 120 within the second slider 70. FIG. 15 shows how the firstand second fastener channels 65, 75 form a passageway for the receptionof the fasteners 105 therein.

The drive mechanism is novel as it uses the fasteners 105 themselves asa part of the drive mechanism. As shown in FIG. 14, the drive mechanism59 has three distinct elements: the first member or slider 60, thesecond member or slider 70, and the plurality of fasteners 105 stored ina serial fashion therebetween. Fasteners 105 are held between thesawteeth 120 with the barbs 107, 108 deflecting outwardly to center thefasteners 105 between the sawteeth 120. First and second legs 110, 111of the fasteners 105 are biased outwardly, contacting the surfaces ofthe sawteeth 120 at an angle as shown. The corners of the legs 110, 111where they contact the first and second sliders 60,70 will dig into andattempt to expand outwardly against the sawteeth if the fasteners 120are moved proximally relative to the first or second slider. Also thedistal ends of the legs can form positive contact with the steps 121 ofthe sawteeth 120. Distal movements of the fasteners within the first andsecond sliders 60,70 slide the corners of the legs 110, 111 along theinclines 122. Additionally, the corners of the barbs 107, 108 contactthe inclines 122 and act in a similar manner as the legs 110, 111 whenthey engage the first and second sliders 60,70. The distal ends of thefirst and second legs 110, 111 are shown positioned within the pocketsat the junction of the step 121 and the incline 122, and are operativelyengaged with the steps 121 and slidingly engaged with the inclines 122.It is the positive contact or engagement of the fasteners 105 with thesteps 121 and sliding contact or engagement with the inclines 122 thatdrives or feeds the plurality of fasteners 105 between the reciprocatingfirst and second sliders 60,70 and places the fastener 105 into tissue.Thus, both the barbs 107, 108 and the legs 110, 111 can propel thefasteners.

To someone skilled in the art, it can be seen that given the elements ofthe drive mechanism 59 described above, distal movement of both of thefirst and second sliders 60, 70 results in operative engagement of thefasteners 105 with the steps 121 of both sliders 60, 70. This operativeengagement with the distally moving sliders 60, 60 will result in distalmovement of the fasteners 105. If one of the sliders such as firstslider 60 is moved distally while the other remains stationary, thefasteners 105 operably couple with and move with the moving slider 60,while slidingly engaging with the stationary slider 70. And, if one ofthe sliders such as first slider 60 moves proximally while the otherremains stationary, the fasteners 105 operatively engage with thestationary slider 70 and remain stationary and slidably engaged with themoving slider 60.

With the above combinations of motions and reactions, there are threedifferent sequences of motion possible with the sliders 60, 70 that willdrive the fasteners 105 distally through the surgical instrument 35(FIG. 3). One of these sequences of motion was selected for use with thesurgical instrument 35 of the present invention, as it is best suited toplace a fastener 105 into tissue. This driving sequence using the drivemechanism 59 of the present invention is shown in a step by step mannerbeginning with the start position shown in FIG. 14, and finishing inFIGS. 18-22. The other two driving sequences will be described later.

The actuator mechanism of the present invention has at least threesequential positions. First, the actuator mechanism moves the first andsecond sliders 60, 70 distally (FIGS. 18, 19) from a first proximalposition (FIG. 14) to a second distal position (FIG. 19). This movementpositively engages the fasteners 105 with the first and second sliders60, 70 and moves the fasteners 105 distally from the first position tothe second position. Moving both the first and second sliders 60, 70(FIG. 14) from a first proximal position to a second distal positionmoves the entire plurality of fasteners 105 distally within the surgicalinstrument 35. That is, each fastener 105 (with the exception of thedistal most fastener 105) now occupies the position of the precedingfastener 105.

Next, as shown in FIGS. 20, 21, the actuator mechanism moves orreciprocates the first slider 60 proximally from the second distalposition back to the first proximal position to opposedly align thesawteeth 120 of the first and second sliders 60, 70. As shown, thefasteners 105 are operatively engaged with the stationary second slider70 and remain stationary (longitudinally) within the shaft 92.

Finally, as shown in FIG. 22 the actuator mechanism moves orreciprocates the second slider 70 proximally from the second distalposition back to the first proximal position, and to realign thesawteeth 120 within the first and second sliders 60, 70. The fasteners105 in operative contact with the stationary first slider 60 remainstationary and in sliding contact with the distally moving second slider70. As shown in FIG. 22, the first and second sliders 60, 70 have placedthe distal most fastener 105 within tissue and have moved distally backto the first position. A new fastener 105 is shown within first andsecond sliders 60, 70, ready for placement within tissue.

As described above, there are two additional embodiments of the presentinvention wherein different sequences of motion are possible with thefirst and second sliders 60, 70. These alternate sequences of motionwill also drive the fasteners 105 distally through the surgicalinstrument 35 (FIG. 3).

In the next or second embodiment, the sequence of motion is to fix oneof the first or sliders such as first slider 60 and to reciprocate theremaining slider 70 distally from the first position to the secondposition and back to the first position.

In the third embodiment, the sequence of motion is altered wherein thefirst and second sliders 60, 70 are reciprocated in opposite directionsat the same time.

The Anatomy

Referring now to FIG. 16, one typical application of the surgicalinstrument of the present invention is a repair of a defect, such as aninguinal hernia 125, located in inguinal tissue such as the inguinalfloor 126. The anatomical structures of the left inguinal anatomy of ahuman patient are illustrated in order to point out the usefulness ofthe present invention.

Generally, the inguinal hernia 125 is accessible through iliacus muscle127. As can be well appreciated, a network of vessels and nerves existin the area of a typical inguinal hernia 125, which requires a surgeonto conduct a hernia repair with great skill and caution. For instance,in the transverse abdominis aponeurosis 128, an internal ring 129permits gastric vessels 130 and Vas deferens 131 to extend therethroughover an edge of inguinal ligament 132. Femoral canal 133 is located nearCooper's ligament 134 and contains external iliac vessels 135 andinferior epigastric vessels 136.

In many cases, the edge of the inguinal ligament 132 and Cooper'sligament 134 serve as anatomical landmarks and support structures forsupporting surgical fasteners such as those mentioned previously. Thearea containing the external iliac vessels 135 and the Vas deferens 131is commonly known as “the Triangle of Doom” to surgeons. Accordingly,the surgeon should avoid injuring any of these vessels described aboveand care must be taken when performing dissection, suturing or fasteningwithin this area.

In FIGS. 16 and 17, a prosthetic or a mesh patch 140 is placed over theinguinal hernia 125 with a surgical grasping instrument 145 as the firststep in the repair of the inguinal hernia 125. The mesh patch 140 mayconsist of any desired configuration, structure or material. However,the mesh patch 140 is preferably made of PROLENE™ (a known polymer madeup of fibers) and preferably configured as mesh. It is within thetraining and comfort zone for surgeons to use the PROLENE™ mesh patch140 since the mesh patch 140 is easily sized, such as providing a sideslot 141, for accommodating the gastric vessels 130 and the Vas deferens131.

As illustrated, the mesh patch 140 is placeable over the inguinal hernia125 for providing a sufficient barrier to internal viscera (not shown)of the abdomen which would otherwise have a tendency to protrude throughthe inguinal hernia 125 and cause the patient a great deal of pain anddiscomfort. FIG. 11 shows a side view of the mesh patch 140 being placedonto the inguinal floor 126. The mesh patch 140 is now attachable to theinguinal floor 126.

The Method

FIGS. 18-23 are also used to illustrate the method of use of thesurgical instrument 35. These cross-sectional side views of the distalend of the shaft 92 show the steps involved in using the surgicalinstrument 35 as it places a novel fastener 105 of the present inventioninto the inguinal floor 126 to attach the mesh patch 140 thereto.

FIG. 18 is a cross-sectional side view of the inguinal floor 126 of thelower abdomen wherein the surgeon has placed the distal end of the shaft92 into the area near the patient's inguinal hernia 125. The surgeon hasselected an attachment point or surgical site and is using the distalend of the surgical instrument 35 to push the mesh patch 140 downwardonto the inguinal floor 126. The distal end of the shaft 92 isdeliberately positioned over an opening 142 within the mesh patch 140for the placement of a fastener 105 therethrough. The position of theend effector 95 within the cross-sectioned shaft 92 indicates that thetrigger 85 has been partially activated by the surgeon. The partialmovement or activation of the trigger 85 is translating or moving thefirst and second sliders 60, 70 distally (downwardly in FIG. 14) fromthe initial position shown in FIG. 14.

As illustrated in FIG. 19, the surgeon has continued to actuate or movethe trigger 85, has moved the trigger 85 to the first position (FIGS. 2,5, and 6), and has fully extended or translated the first and secondsliders 60, 70 of the end effector 95 from the shaft 92. The extendedend effector 95 has penetrated through the opening 142 within the meshpatch 140 and into the inguinal floor 126. Although shielded from tissuecontact by the end effector 95, the first and second barbs 107, 108 ofthe distal most fastener 105 are placed within tissue of the inguinalfloor 126.

Continued actuation of the trigger 85 by the surgeon moves the trigger85 from the from the first partially closed position shown in FIGS. 5and 6 to the second fully closed position shown in FIGS. 7 and 8. Inthis position, the indexing mechanism of the surgical instrument 35 ofthe preferred invention is actuated and an automatic sequence of actionsoccurs beginning with the reciprocation or movement of the first slider60 proximally as indicated by the arrow in FIG. 20.

In FIG. 20, the first slider 60 has partially moved or retracted intothe shaft 92. This action has released the first and second barbs 107,108 of the distal most fastener 105 from the constrained condition shownin FIG. 19 and fixably engaged the first barb 107 with the tissue of theinguinal floor 126. The barbs 107, 108 of the distal fastener 105, whenreleased, snap open to the positions shown in FIG. 20, bending thedistal most fastener 105.

Once actuated, the first slider 60 continues to move distally into thesurgical instrument 35 until it returns to the to the initial startposition within the shaft 92 as shown in FIG. 21. When the first slider60 is at this position, the second slider 70 is automatically releasedto move or reciprocate distally into the shaft 92 as indicated by thearrow.

As shown in FIG. 21, the first slider 60 is at to the initial startposition of FIG. 10, fully releasing the distal fastener 105. The secondbarb 108 and second leg 111 bias the distal fastener 105 into theportion of the shaft 92 previously occupied by the first feed member 61of the first slider 60. This bias further engages the first barb 107 ofthe distal fastener 105 with the inguinal floor 126.

In FIG. 22, the second slider 70 has automatically retracted distallyinto the shaft 92 to the first start position and has fully released thesecond barb 108 of the distal fastener 105 to engage with the tissue ofthe inguinal floor 126. The second leg 111 of the distal fastener 105has also been released from the second slider 70 and both the first andthe second legs 110, 111 have expanded outwardly within the shaft 92.

Finally, the surgeon releases the trigger 85 which returns to theinitial open position of FIG. 1 and withdraws the distal end of theshaft 92 away from the mesh patch 140, and from the distal fastener 105that is engaged or attached to the inguinal floor 126. As shown in FIG.23, the first and second barbs 107, 108 of the fastener 105 of thepresent invention are firmly planted within the inguinal floor 126 andthe first and second legs 110, 111, when released from the shaft 92,snap back to their original everted shape (FIGS. 9 and 10). The meshpatch 140 is fixedly held against the inguinal floor 126 by the firstand second legs 110, 111 of the fastener 105. The surgical instrument isnow ready to attach the mesh patch 140 at another site. To accomplishthis, the surgeon merely repositions the distal end of the shaft 92 atanother surgical site and actuates the trigger 85 to place or attachanother fastener 105 into the inguinal floor 126. This process iscontinued until the mesh patch 140 is satisfactorily attached to theinguinal floor 126.

The Lockout Mechanism

The surgical instrument 35 of the present invention (FIG. 1) contains aplurality of fasteners 105. As the surgeon repeatedly fires theinstrument during the attachment of the prosthetic, the number offasteners 105 stored therein steadily decreases. When the final fastener105 is placed into tissue, the surgeon has no way of knowing when theinstrument is emptied of fasteners 105 and can attempt to fire the emptysurgical instrument 35 on tissue. A lockout mechanism of the preferredinvention is provided within the surgical instrument 35 to lock thetrigger 85 when the surgical instrument 35 is empty.

As described previously, the trigger 85 has a lockout arm 88 fixablyattached to and extending therefrom. Actuation of the trigger 85 movesthe lockout arm 88 from the initial position of FIG. 3 to a firstpartially closed position within the handle 40, and into contact withthe lockout wheel 100 rotatably mounted within the wheel receptacle 48as shown in FIG. 24.

In FIG. 24, the trigger 85 has rotated lockout arm 88 counter-clockwiseto engage with a tooth 101 of the lockout wheel 100. A lockout tab 102is located just above the lockout arm 88 and extends outwardly from thelockout wheel 100. A lockout detent 103 is attached to and extendsoutwardly from the right handle half 41 towards the viewer to operablyengage with the lockout wheel 100. A small cutout is provided within thelower portion of the lockout wheel 100 to show the outwardly extendingend of the lockout detent 103.

FIG. 25 is a distal view taken across cross-section 25-25 in FIG. 24,and hows the necessary portions of the key elements so that the readercan understand the operation of the lockout mechanism. The lockoutmechanism of the present invention consists of the lockout wheel 100,the lockout detent 103 and the lockout arm 88 extending from the trigger85. Lockout wheel 100 is shown perpendicular to the axis of rotation andhas lockout detent 103 operably engaged with a lockout tooth 101 toprevent clockwise rotation of the lockout wheel 100. The lockout arm iscross-sectioned by the cutting plane 25-25 and two cross-sections aretaken across the lockout arm 88. A first section 88 a is taken acrossthe distal end of the lockout arm 88 when the lockout arm is in theinitial position, and a second section 88 b is taken across the lockoutarm 88 to show the actual position of the lockout arm 88. An arrow isprovided to identify the direction of motion of the second section 88 bof the lockout arm 88.

The lockout wheel 100 of the present invention has the same number ofteeth 101 around its circumference as the surgical instrument 35 hasfasteners 105. When the trigger 85 is fully actuated to place a fastener105 into tissue, the lockout arm 88 is brought into contact with thelockout wheel 100 to rotate or index the lockout wheel 100counter-clockwise one tooth 101 as shown in FIG. 26. When the trigger 85is released after the actuation, the lockout detent 103 prevents thelockout wheel 100 from rotating clockwise as the lockout arm 88 returnsto the initial position 88 a. Thus, one full actuation of the trigger 85rotates the locking wheel 100 one tooth 101, and firing all of thefasteners 105 rotates the lockout wheel 100 one full revolution.

FIGS. 27-29 show how the lockout tab 102 operatively locks the lockoutarm 88 (and the trigger 85) in the fully actuated or closed position asthe last fastener 105 is fired. In FIG. 27, the lockout wheel hasrotated nearly one full revolution from the first position of FIG. 25.This is indicated by the new position of the lockout tab 102. The secondsection 88 b of the lockout arm 88 is shown moving upwardly, has justcleared the lockout tab 102, and is contacting the final lockout tooth101. In FIG. 28, the second section 88 b of the lockout arm 88 is shownin the fully actuated or closed position and the lockout tab 102 hasrotated in under the second section 88 b of the lockout arm 88. When thetrigger 85 is released, the second section 88 b of the lockout arm 88moves downwardly to contact the lockout tab 102 and rotates the lockoutwheel 100 clockwise to engage tooth 101 with the lockout detent 103(FIG. 29). The engagement with the lockout detent 103 prevents thelockout wheel 100 from rotating clockwise and locks the second section88 b of the lockout arm 88. Thus, in FIG. 29, the second section 88 b ofthe lockout arm 88 (and trigger 85) is locked in the first partiallyclosed position by the lockout detent 103 which prevents the trigger 85of the surgical instrument 35 from opening.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. Accordingly, it isintended that the invention be limited only by the spirit and scope ofthe appended claims.

What is claimed is:
 1. A delivery device for delivering a plurality ofindividual surgical fasteners, said delivery device comprising: a. adrive mechanism having distal and proximal ends, said drive mechanismcomprising first and second opposing members, said members beingmoveable proximally and distally with respect to said delivery device,and individually with respect to each other; b. at least one surgicalfastener located between said first and said second members, each ofsaid at least one surgical fasteners having a proximal end and a distalend; c. an actuator having at least three sequential positions, a firstposition for moving said drive mechanism distally, and a second positionfor moving said first member proximally, thereby partially deployingsaid distal end of said fastener, and a third position for moving saidsecond member proximally, thereby fully deploying said distal end ofsaid fastener.
 2. The delivery device of claim 1 wherein the first andsecond members have inner surfaces having a plurality projections spacedthereon, said projections engaging said fasteners.
 3. The deliverydevice of claim 2 wherein said projections are spaced apart a distancebetween about 8 inches and between 0.005 inches.
 4. The delivery deviceof claim 2 wherein said projections are sawteeth.
 5. The delivery deviceof claim 1 wherein said fasteners comprise a body having a distal end, aproximal end, and a longitudinal axis therebetween, said fastenersinclude at least one barb extending axially away from said distal end,and one barb extending axially away from said second end.
 6. Thedelivery device of claim 4 wherein said barbs engage inner surfaces ofsaid first and second members.
 7. The delivery device of claim 5 whereinthe fastener is formed from stainless steel.
 8. The delivery device ofclaim 5 wherein said fasteners are made from a superelastic alloy. 9.The delivery device of claim 7 wherein superelastic alloy is a nickeltitanium alloy.
 10. The delivery device of claim 1 having a plurality offasteners located between said first and second members, and whereinsaid fasteners are not engaging one another and are spaced apart fromone another.
 11. The delivery device of claim 1 wherein the distal endsof said first and second members are sharp.
 12. The delivery device ofclaim 1 wherein the distal ends of said first and second members havepenetrating members attached thereto.
 13. A delivery device fordelivering a plurality of individual surgical fasteners, said deliverydevice comprising: a. a drive mechanism having distal and proximal endsand a longitudinal axis therebetween, said drive mechanism comprisingfirst and second opposing members, said members being moveableproximally and distally with respect to said delivery device, andindividually with respect to each other; b. a plurality of surgicalfasteners disposed longitudinally within said drive mechanism betweensaid first and said second members, each of said at least one surgicalfasteners having a proximal end and a distal end; c. an actuator fordeploying one of said fasteners and moving said plurality said fastenersdistally with respect to said longitudinal axis, said actuator causingsaid drive mechanism to move in at least three sequential positions, afirst position moving said drive mechanism and said plurality offasteners distally, and thereafter moving said first member proximally,thereby partially deploying said distal end of said fastener, andthereafter moving said second member proximally, thereby fully deployingsaid distal end of said fastener.
 14. The delivery device of claim 13wherein the first and second members have inner surfaces having aplurality projections spaced thereon, said projections engaging saidfasteners.
 15. The delivery device of claim 14 wherein said projectionsare spaced apart a distance between about 8 inches and between 0.005inches.
 16. The delivery device of claim 14 wherein said projections aresawteeth.
 17. The delivery device of claim 13 wherein said fastenerscomprise a body having a distal end, a proximal end, and a longitudinalaxis therebetween, said fasteners include at least one barb extendingaxially away from said distal end, and one barb extending axially awayfrom said second end.
 18. The delivery device of claim 16 wherein saidbarbs engage inner surfaces of said first and second members.
 19. Thedelivery device of claim 17 wherein the fastener is formed fromstainless steel.
 20. The delivery device of claim 17 wherein saidfasteners are made from a superelastic alloy.
 21. The delivery device ofclaim 19 wherein superelastic alloy is a nickel titanium alloy.
 22. Thedelivery device of claim 13 wherein said fasteners are not engaging oneanother and are spaced apart from one another.
 23. The delivery deviceof claim 13 wherein the distal ends of said first and second members aresharp.
 24. The delivery device of claim 13 wherein the distal ends ofsaid first and second members have penetrating members attached thereto.25. A delivery device for delivering a plurality of individual surgicalfasteners, said delivery device comprising: a. a drive mechanism havingdistal and proximal ends, said drive mechanism comprising first andsecond opposing members, said members being moveable proximally anddistally with respect to said delivery device, and individually withrespect to each other; b. at least one surgical fastener located betweensaid first and said second members, each of said at least one surgicalfasteners having a proximal end and a distal end; c. a means for movingsaid drive mechanism distally, and thereafter moving said first memberproximally, thereby partially deploying said distal end of saidfastener, and thereafter moving said second member proximally, therebyfully deploying said distal end of said fastener.
 26. The deliverydevice of claim 25 wherein the first and second members have innersurfaces having a plurality projections spaced thereon, said projectionsengaging said fasteners.
 27. The delivery device of claim 26 whereinsaid projections are spaced apart a distance between about 8 inches andbetween 0.005 inches.
 28. The delivery device of claim 6 wherein saidprojections are sawteeth.
 29. The delivery device of claim 25 whereinsaid fasteners comprise a body having a distal end, a proximal end, anda longitudinal axis therebetween, said fasteners include at least onebarb extending axially away from said distal end, and one barb extendingaxially away from said second end.
 30. The delivery device of claim 28wherein said barbs engage inner surfaces of said first and secondmembers.
 31. The delivery device of claim 29 wherein the fastener isformed from stainless steel.
 32. The delivery device of claim 29 whereinsaid fasteners are made from a superelastic alloy.
 33. The deliverydevice of claim 31 wherein superelastic alloy is a nickel titaniumalloy.
 34. The delivery device of claim 25 wherein said fasteners arenot engaging one another and are spaced apart from one another.
 35. Thedelivery device of claim 25 wherein the distal ends of said first andsecond members are sharp.
 36. The delivery device of claim 25 whereinthe distal ends of said first and second members have penetratingmembers attached thereto.
 37. A delivery device for delivering aplurality of individual surgical fasteners, said delivery devicecomprising: a. a drive mechanism having distal and proximal ends and alongitudinal axis therebetween, said drive mechanism comprising firstand second opposing members, said members being moveable proximally anddistally with respect to said delivery device, and individually withrespect to each other; b. a plurality of surgical fasteners disposedlongitudinally within said drive mechanism between said first and saidsecond members, each of said at least one surgical fasteners having aproximal end and a distal end; c. a means for deploying one of saidfasteners and for moving said plurality said fasteners distally withrespect to said longitudinal axis, said means moving said drivemechanism and said plurality of fasteners distally, and thereaftermoving said first member proximally, thereby partially deploying saiddistal end of said fastener, and thereafter moving said second memberproximally, thereby fully deploying said distal end of said fastener.38. The delivery device of claim 37 wherein the first and second membershave inner surfaces having a plurality projections spaced thereon, saidprojections engaging said fasteners.
 39. The delivery device of claim 38wherein said projections are spaced apart a distance between about 8inches and between 0.005 inches.
 40. The delivery device of claim 38wherein said projections are sawteeth.
 41. The delivery device of claim37 wherein said fasteners comprise a body having a distal end, aproximal end, and a longitudinal axis therebetween, said fastenersinclude at least one barb extending axially away from said distal end,and one barb extending axially away from said second end.
 42. Thedelivery device of claim 41 wherein said barbs engage inner surfaces ofsaid first and second members.
 43. The delivery device of claim 42wherein the fastener is formed from stainless steel.
 44. The deliverydevice of claim 42 wherein said fasteners are made from a superelasticalloy.
 45. The delivery device of claim 44 wherein superelastic alloy isa nickel titanium alloy.
 46. The delivery device of claim 37 whereinsaid fasteners are not engaging one another and are spaced apart fromone another.
 47. The delivery device of claim 37 wherein the distal endsof said first and second members are sharp.
 48. The delivery device ofclaim 37 wherein the distal ends of said first and second members havepenetrating members attached thereto.